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BackgroundCritical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI.MethodsThis 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers.ResultsA total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American.ConclusionsSCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

Abstract Background American Indians (AI) have the highest smoking rates of any ethnic group in the US (40.8%), followed most closely by African Americans (24.3%) and European Americans (23.6%). AI smokers also have more difficulty quitting smoking compared to other ethnic groups, evidenced by their significantly lower quit ratios, and are among the least successful in maintaining long term abstinence. While health disparities like these have existed for years among AI, the epidemiology of smoking and nicotine dependence has not been optimally described among this underserved population. Our overarching hypothesis is that the susceptibility of AI to cigarette smoking and nicotine dependence and its consequences has both an underlying nicotine metabolism component as well as psychosocial, cultural, and environment causes. We are well-positioned to explore this issue for the first time in this population. Our objective is to establish a cohort of AI tribal college/university students to determine the predictors of smoking initiation (non-use to experimentation), progression (experimentation to established use), and cessation (established use to cessation). Much of what is known about the process of smoking initiation and progression comes from quantitative studies with non-Native populations. Information related to smoking use among AI tribal college/university (TCU) students is entirely unknown and critically needs further investigation. This study will be the first of its kind among AI college students who are at the highest risk among all ethnic groups for tobacco dependence. Methods/design First year students at Haskell Indian Nations University in Kansas will be recruited over four consecutive years and will be surveyed annually and repeatedly through year 5 of the study. We will use both longitudinal quantitative surveys and qualitative focus group methods to examine key measures and determinants of initiation and use among this high risk group.

Objective: The purpose of this study was to examine knowledge, awareness, and support for campus smoke-free policies. Participants: 1,256 American Indian tribal college students from three tribal colleges in the Midwest and Northern Plains. Methods: Data are from an observational cross-sectional study of American Indian tribal college students, collected through a web-based survey. Results: Only 40% of tribal college students reported not being exposed to second hand smoke in the past 7 days. A majority of nonsmokers (66%) agreed or strongly agreed with having a smoke-free campus, while 34.2% of smokers also agreed or strongly agreed. Overall, more than a third (36.6%) of tribal college students were not aware of their campus smoking policies. Conclusions: Tribal campuses serving American Indian students have been much slower in adopting smoke-free campus policies. Our findings show that tribal college students would support a smoke-free campus policy.

Introduction: Rural and under-resourced urban communities face unique challenges in addressing patients' social determinants of health needs (SDoH). Community health workers (CHWs) can support patients experiencing social needs, yet little is known about how rural and under-resourced primary care clinics are screening for SDoH or utilizing CHWs. Methods: Interviews were conducted with primary care clinic providers and managers across a geographically large and predominately rural state to assess screening practices for SDoH and related community resources, and perspectives on using CHWs to address SDoH. Interviews were conducted by phone, recorded, and transcribed. Data were analyzed using thematic analysis. We completed interviews with 27 respondents (12 providers and 15 clinic managers) at 26 clinics. Results: Twelve (46.1%) clinics had a standardized process for capturing SDoH, but this was primarily limited to Medicare wellness visits. Staffing and time were identified as barriers to proper SDoH screening. Lack of transportation and affordable medication were the most cited SDoH. While respondents were all aware of CHWs, only 8 (30.8%) included a CHW on their care team. Perceived barriers to engaging CHWs included cost, space, and availability of qualified CHWs. Perceived benefits of engaging CHWs in their practice were: assisting patients with navigating resources and programs, relieving clinical staff of non-medical tasks, and bridging language barriers. Conclusions: Rural and under-resourced primary care clinics need help in identifying and addressing SDoH. CHWs could play an important part in addressing social needs and promoting preventive care if financial constraints could be addressed and local CHWs could be trained. [ABSTRACT FROM AUTHOR]

Balanced two-arm designs are more powerful than unbalanced designs and, consequently, Bayesian adaptive designs (BADs) are less powerful. However, when considering other subject- or community-focused design characteristics, fixed two-arm designs can be suboptimal. We use a novel approach to identify the best two-arm study design, taking into consideration both the statistical perspective and the community’s perception. Data envelopment analysis (DEA) was used to estimate the relative performance of competing designs in the presence of multiple optimality criteria. The two-arm fixed design has enough deficiencies in subject- and community-specific benefit to make it the least favorable study design. [ABSTRACT FROM PUBLISHER]

Background: Compared to non-Hispanic white college students, American Indian (AI) tribal college students have the highest smoking prevalence in the U.S. (~34%). Culturally-tailored smoking cessation programs have proven to be successful in reducing smoking rates but may require new methods to reach college students. Currently, there is little documentation on the development and success of Internet-based smoking interventions for AI tribal college students. Objectives: To develop an Internet-based smoking cessation program (Internet-All Nations Breath of Life or I-ANBL) with tribal college students. Methods: We conducted six focus groups (n=41) at a tribal college. Focus groups included tribal college students who smoked and groups were stratified by sex. Transcripts were analyzed using insider and outsider perspectives. After analysis, an Internet-based smoking cessation program was developed, based on insight gained. Results: Numerous suggestions for creating the program were offered. There was consensus on the need for a variety of visuals including cultural images, videos, and interactive content. The students also suggested the integration of familiar platforms such as Facebook™. Conclusion: When culturally tailoring a web-based smoking cessation program for tribal college students, it is important to incorporate cultural aspects and recognize gender differences. One important aspect is to recognize that for many AI, tobacco is a sacred plant and images of tobacco should be respectful. Now that this intervention has been developed, next we will test it for efficacy in a randomized controlled trial. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic added to the decades of evidence that public health institutions are routinely stretched beyond their capacity. Community health workers (CHWs) can be a crucial extension of public health resources to address health inequities, but systems to document CHW efforts are often fragmented and prone to unneeded redundancy, errors, and inefficiency., Objective: We sought to develop a more efficient data collection system for recording the wide range of community-based efforts performed by CHWs., Methods: The Communities Organizing to Promote Equity (COPE) project is an initiative to address health disparities across Kansas, in part, through the deployment of CHWs. Our team iteratively designed and refined the features of a novel data collection system for CHWs. Pilot tests with CHWs occurred over several months to ensure that the functionality supported their daily use. Following implementation of the database, procedures were set to sustain the collection of feedback from CHWs, community partners, and organizations with similar systems to continually modify the database to meet the needs of users. A continuous quality improvement process was conducted monthly to evaluate CHW performance; feedback was exchanged at team and individual levels regarding the continuous quality improvement results and opportunities for improvement. Further, a 15-item feedback survey was distributed to all 33 COPE CHWs and supervisors for assessing the feasibility of database features, accessibility, and overall satisfaction., Results: At launch, the database had 60 active users in 20 counties. Documented client interactions begin with needs assessments (modified versions of the Arizona Self-sufficiency Matrix and PRAPARE [Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences]) and continue with the longitudinal tracking of progress toward goals. A user-specific automated alerts-based dashboard displays clients needing follow-up and upcoming events. The database contains over 55,000 documented encounters across more than 5079 clients. Available resources from over 2500 community organizations have been documented. Survey data indicated that 84% (27/32) of the respondents considered the overall navigation of the database as very easy. The majority of the respondents indicated they were overall very satisfied (14/32, 44%) or satisfied (15/32, 48%) with the database. Open-ended responses indicated the database features, documentation of community organizations and visual confirmation of consent form and data storage on a Health Insurance Portability and Accountability Act-compliant record system, improved client engagement, enrollment processes, and identification of resources., Conclusions: Our database extends beyond conventional electronic medical records and provides flexibility for ever-changing needs. The COPE database provides real-world data on CHW accomplishments, thereby improving the uniformity of data collection to enhance monitoring and evaluation. This database can serve as a model for community-based documentation systems and be adapted for use in other community settings., (©Harshdeep Acharya, Kevin J Sykes, Ton Mirás Neira, Angela Scott, Christina M Pacheco, Matthew Sanner, Elizabeth Ablah, Kevin Oyowe, Edward F Ellerbeck, K Allen Greiner, Erin A Corriveau, Sarah Finocchario-Kessler. Originally published in JMIR Formative Research (https://formative.jmir.org), 01.04.2024.)

Background: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI., Methods: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers., Results: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American., Conclusions: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 Published by Elsevier B.V.)

Objectives: American Indians are more likely to smoke, less likely to have smoke-free homes, and potentially less likely to have worksite smoke-free policies. We examined correlates of smoke-free policies at home and work among a community-based sample of American Indians in the Midwest., Methods: We examined correlates of smoke-free policies at home and work in a sample of American Indians in the Midwest using a community-based participatory research approach., Results: 66.7% were nonsmokers, 15.6% smoked on some days, and 17.6% smoked every day. The majority (72.4%) had complete smoke-free home policies, 13.1% had partial restrictions, and 14.5% had no rules. Moreover, 62.7% had complete smoke-free worksite policies, 27.9% had partial policies, and 9.4% had no worksite smoke-free policies. Factors associated with having a complete smoke-free home policy included being a college graduate (p=.005) and a nonsmoker versus a nondaily (p=.006) or a daily smoker (p<.001). Correlates of having a complete smoke-free worksite policy included being female (p=.005) and a nonsmoker versus a nondaily (p=.03) or a daily smoker (p<.001). Having complete worksite policies was associated with having smoke-free homes (p<.001)., Conclusions: Having complete worksite policies was related to having smoke-free home policies; both were associated with being a nonsmoker.